912250

Boiron — FEI 3004611192

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 15, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Messimy (France)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
138821 CFR 211.101(d)Component addition checked by 2nd person
144821 CFR 211.111Establishment of time limitations
180121 CFR 211.84(a)Components withheld from use pending release
188521 CFR 211.165(b)Microbiological testing
202621 CFR 211.192Quality control unit review of records
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete